CN102599494A - Process for preparing three-layer effervescent tablet containing vitamin C - Google Patents

Process for preparing three-layer effervescent tablet containing vitamin C Download PDF

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Publication number
CN102599494A
CN102599494A CN2011103382697A CN201110338269A CN102599494A CN 102599494 A CN102599494 A CN 102599494A CN 2011103382697 A CN2011103382697 A CN 2011103382697A CN 201110338269 A CN201110338269 A CN 201110338269A CN 102599494 A CN102599494 A CN 102599494A
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China
Prior art keywords
layer
acid
disintegrant
sodium
vitamin
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Pending
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CN2011103382697A
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Chinese (zh)
Inventor
张国栋
刘锋
张勇
丁亚芳
史解矛
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DSM Jiangshan Pharmaceutical Jiangsu Co Ltd
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Aland Jiangsu Nutraceutical Co Ltd
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Priority to CN2011103382697A priority Critical patent/CN102599494A/en
Publication of CN102599494A publication Critical patent/CN102599494A/en
Pending legal-status Critical Current

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Abstract

The invention discloses a process for preparing a three-layer effervescent tablet containing vitamin C. The process comprises the steps of: (1) carrying out wet-process granulation on slurry prepared from an acid source and a bonding agent for an internally added disintegrating agent to prepare particles, and uniformly mixing the particles with the vitamin C, the disintegrating agent and a lubricating agent to serve as a first layer for later use; (2) taking materials used as a middle isolation layer as a second layer for later use; (3) carrying out wet-process granulation on a carbon dioxide source, lactose and the internally added disintegrating agent to prepare particles, and uniformly mixing the particles with pigment, a sweetener, the disintegrating agent and the lubricating agent to serve as a third layer; and (4) pressing together to obtain a three-layer tablet. A product prepared according to the invention has the advantages of smooth and bright surface, uniform glossiness, good effervescent effect, favorable stability, smaller expansion under a high humidity state, convenience in carrying, and simpleness for oral administration.

Description

A kind of preparation technology who contains ascorbic three layers of effervescent tablet
Technical field:
The present invention relates to field of health care food, relate in particular to a kind of preparation technology who contains ascorbic three layers of effervescent tablet.
Background technology;
Effervescent tablet is to be a kind of novel form that disintegrant is processed with the effervesce material; After dropping in the water; Acid source wherein and carbon dioxide source react rapidly and generate a large amount of carbon dioxides; Impel dissolving within a short period of time of whole tablet, have characteristics such as onset is rapid, bioavilability is high, easy to carry, with the characteristics of solid pharmaceutical preparation and liquid preparation.
Vitamin C is the L-ascorbic acid again, is a kind of water soluble vitamin, is to keep one of necessary nutrient of human body normal health, can cause scurvy during shortage.Human body is owing to lack and to change into the necessary gulonolactone oxidase of vitamin C, self can not synthetic vitamin C, and must from food, replenish.If be deficient in vitamin C in the diet, will cause scurvy, show as wound and ulcer and be difficult for healing, subcutaneous, mucous membrane and hemorrhage of muscle.The vitamin C decapacitation prevents and treats outside the scurvy, also has other important physical effects.Vitamin C can utilize its reproducibility, improves transhipment and the utilization of body to iron, so can correct anaemia; It can promote that ferrihemoglobin is reduced into hemoglobin, helps to eliminate cyanosis; Vitamin C can prevent the accumulation of histamine, helps the degraded and the removing of histamine, can alleviate cold symptoms so take vitamin C after catching a cold; Vitamin C also has the effect of antiatherosclerosis, prevention coronary heart disease; In addition, it also can prevent cataract and crystalline lens to blur disease, anti-ageing, enhancing body immunity etc.It is thus clear that vitamin C is extremely important to human body, can not lack, should note ascorbic suitably additional in daily life.
The tradition effervescent tablet mixes the back compressing tablet with effervescent couple (being acid source and carbon dioxide source) usually, and after effervescent tablet placed water, reaction generated great amount of carbon dioxide gas and disintegration rapidly by effervescent couple.Because effervescent couple mixes each other, this type effervescent tablet is easy to reaction and emits gas under super-humid conditions, not only can destroy the outward appearance of tablet, influences the disintegration of tablet, and functional component is reduced.In addition, because effervescent couple mixes each other, traditional effervescent tablet is very high to the moisture requirement of raw material, and is also very high to the humidity requirement of production environment when producing.
Summary of the invention:
The purpose of this invention is to provide a kind of preparation technology who contains ascorbic three layers of effervescent tablet, the product bioavilability that makes is high, has good stable property and under high wet condition, expands less.
The objective of the invention is to realize like this; A kind of preparation technology who contains ascorbic three layers of effervescent tablet is characterized in that: (1) with acid source, in evenly afterwards subsequent use with vitamin C, disintegrant, mix lubricant with disintegrant as ground floor with the particle that the slurries of adhesive preparation adopt wet granulation to make; (2) it is subsequent use as the second layer to be used as the material of interval absciss layer; (3) with carbon dioxide source, lactose, in after disintegrant wet granulation together with the particle that makes and pigment, sweetener, disintegrant, mix lubricant evenly the back as the 3rd layer; (4) be pressed into three-layer tablet together; Described acid source is citric acid, tartaric acid, fumaric acid, adipic acid or malic acid; Described disintegrant is carboxyrnethyl starch sodium, Ac-Di-Sol, PVPP or polyvinyl pyrrolidone; Described interval absciss layer is lactose, sorbierite, sweet mellow wine or glucose; Described adhesive is water, ethanol, polyvinylpyrrolidone or low-substituted hydroxypropyl cellulose; Described lubricant is dolomol, talcum powder, superfine silica gel powder, sodium stearyl fumarate, lauryl sodium sulfate, L-leucine, Macrogol 6000, Macrogol 4000 or Sodium Benzoate; Described carbon dioxide source is sodium acid carbonate, sodium carbonate or saleratus.
The product surface that the present invention makes smooth bright clean, color and luster is even, effervesce is effective, have good stable property under high wet condition, expand less, easy to carry, be easy to oral.
The specific embodiment:
Containing ascorbic three layers of effervescent tablet main component is: every contains carbon dioxide source 100-1600mg, acid source 100-1600mg, disintegrant 10-500mg; Lactose 10-1000mg, vitamin C 10-2000mg, adhesive 10-500mg; Sweetener 1-100mg; Essence 1-100mg, lubricant 100-800mg, separation layer 10-600mg.
Below in conjunction with specific embodiment the present invention is further specified:
Embodiment: contain the preparation of ascorbic three layers of effervescent tablet
Ground floor: citric acid 1050mg
PVPP 215mg
Vitamin C 200mg
Macrogol 6000 90mg
30 POVIDONE K 30 BP/USP 30 20mg
Water is an amount of
The second layer: lactose 200mg
The 3rd layer: sodium acid carbonate 750mg
Lactose 500mg
PVPP 100mg
Aspartame 20mg
Essence 10mg
Macrogol 6000 90mg
30 POVIDONE K 30 BP/USP 30 35mg
Water is an amount of
Prepare according to following step:
1. the preparation of particulate fraction in the ground floor: using suitable quantity of water to be configured to concentration 30 POVIDONE K 30 BP/USP 30 is 5~20% binder solution, and fully stirring and dissolving is to light yellow transparent solution.
2. citric acid is pulverized, crossed 60~120 mesh sieves;
3. with stirring mixing 1~10 minute in citric acid and the partial cross-linked PVP input wet granulator;
4. the solution that adds the adhesive of the configuration in the step 1 evenly, slowly, liquid feeding is granulated while stirring, process grain after, strict control EAT, drying.Cross 12~20 mesh sieves, make the citric acid particle;
5. the particle that makes in the step 4 and vitamin C, remaining PVPP and Macrogol 6000 are mixed, subsequent use as the ground floor material;
6. the preparation of particulate fraction in the 3rd layer: using suitable quantity of water to be configured to concentration 30 POVIDONE K 30 BP/USP 30 is 5~20% binder solution, and fully stirring and dissolving is to light yellow transparent solution.
7. sodium acid carbonate, lactose are crossed 80~120 mesh sieves;
8. sodium acid carbonate, lactose and partial cross-linked PVP are dropped in the wet granulator and stirred mixing 1~10 minute;
9. the solution that adds the adhesive of the configuration in the step 6 evenly, slowly, liquid feeding is granulated while stirring, process grain after, strict control EAT, drying is crossed 12~20 mesh sieves, makes sodium bicarbonate particle;
10. with the particle that makes in the step 9 and Aspartame, essence, remaining PVPP and Macrogol 6000 mixing, subsequent use as the 3rd layer of material;
11. add the ground floor material, precompressed; Add second layer material, precompressed once more; Add the 3rd layer and directly be pressed into tablet, promptly get.
The prepared three layers of effervescent tablet smooth surface of the foregoing description bright clean, color and luster is even, effervesce is effective, taste is fit to, each item index all meets related request.
Material used in the foregoing description is crossed 60~120 mesh sieves, mix, direct tablet compressing is processed common effervescent tablet, places the container of different humidity with three layers of effervescent tablet in the foregoing description, with 7 days after take out, measure diameter, the result sees the following form.
Figure 20111033826971000021
Can be known that by last table along with the increase of humidity in the container, the diameter of three layers of effervescent tablet and common effervescent tablet all increases, tablet expands.Compare with common effervescent tablet, three layers of effervescent tablet expansion under high wet condition are less.When relative humidity in the container less than 55% the time, the outward appearance of three layers of effervescent tablet is no change almost, integrality is better.

Claims (1)

1. preparation technology who contains ascorbic three layers of effervescent tablet is characterized in that: (1) with acid source, in evenly afterwards subsequent use with vitamin C, disintegrant, mix lubricant with disintegrant as ground floor with the particle that the slurries of adhesive preparation adopt wet granulation to make; (2) it is subsequent use as the second layer to be used as the material of separation layer; (3) with carbon dioxide source, lactose, in after disintegrant wet granulation together with the particle that makes and pigment, sweetener, disintegrant, mix lubricant evenly the back as the 3rd layer; (4) be pressed into three-layer tablet together; Described acid source is citric acid, tartaric acid, fumaric acid, adipic acid or malic acid; Described disintegrant is carboxyrnethyl starch sodium, Ac-Di-Sol, PVPP or polyvinyl pyrrolidone; Described interval absciss layer is lactose, sorbierite, sweet mellow wine or glucose; Described adhesive is water, ethanol, polyvinylpyrrolidone or low-substituted hydroxypropyl cellulose; Described lubricant is dolomol, talcum powder, superfine silica gel powder, sodium stearyl fumarate, lauryl sodium sulfate, L-leucine, Macrogol 6000, Macrogol 4000 or Sodium Benzoate; Described carbon dioxide source is sodium acid carbonate, sodium carbonate or saleratus.
CN2011103382697A 2011-11-01 2011-11-01 Process for preparing three-layer effervescent tablet containing vitamin C Pending CN102599494A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102824313A (en) * 2012-09-18 2012-12-19 东北制药(沈阳)科技发展有限公司 Vitamin C effervescent granule and preparation method thereof
CN103462002A (en) * 2013-08-13 2013-12-25 深圳市麦金利实业有限公司 Vitamin c effervescent tablet and preparation method thereof
CN104434864A (en) * 2014-11-19 2015-03-25 峨眉山通惠制药有限公司 Medicinal effervescent tablet and preparation method thereof
CN107753459A (en) * 2017-10-26 2018-03-06 安徽世龙生物医药科技有限公司 A kind of vitamin C effervescent tablet and preparation method thereof
CN110327303A (en) * 2019-08-15 2019-10-15 威海百合生物技术股份有限公司 A kind of iron vitamin C tablet and preparation method thereof
CN116114881A (en) * 2021-11-15 2023-05-16 华熙生物科技股份有限公司 Three-layer freeze-dried flash-release tablet containing hyaluronic acid and preparation method thereof

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CN1345554A (en) * 2000-09-26 2002-04-24 江苏板桥药业有限责任公司 Gingkgo vitamin C effervescent tablets
CN101484149A (en) * 2006-07-27 2009-07-15 赢创罗姆有限责任公司 Pharmaceutical form with multilayer separating layer

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Publication number Priority date Publication date Assignee Title
CN1345554A (en) * 2000-09-26 2002-04-24 江苏板桥药业有限责任公司 Gingkgo vitamin C effervescent tablets
CN101484149A (en) * 2006-07-27 2009-07-15 赢创罗姆有限责任公司 Pharmaceutical form with multilayer separating layer

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102824313A (en) * 2012-09-18 2012-12-19 东北制药(沈阳)科技发展有限公司 Vitamin C effervescent granule and preparation method thereof
CN102824313B (en) * 2012-09-18 2014-09-24 东北制药集团沈阳第一制药有限公司 Vitamin C effervescent granule and preparation method thereof
CN103462002A (en) * 2013-08-13 2013-12-25 深圳市麦金利实业有限公司 Vitamin c effervescent tablet and preparation method thereof
CN104434864A (en) * 2014-11-19 2015-03-25 峨眉山通惠制药有限公司 Medicinal effervescent tablet and preparation method thereof
CN104434864B (en) * 2014-11-19 2017-06-09 峨眉山通惠制药有限公司 A kind of medicine effervescent tablet and preparation method thereof
CN107753459A (en) * 2017-10-26 2018-03-06 安徽世龙生物医药科技有限公司 A kind of vitamin C effervescent tablet and preparation method thereof
CN110327303A (en) * 2019-08-15 2019-10-15 威海百合生物技术股份有限公司 A kind of iron vitamin C tablet and preparation method thereof
CN116114881A (en) * 2021-11-15 2023-05-16 华熙生物科技股份有限公司 Three-layer freeze-dried flash-release tablet containing hyaluronic acid and preparation method thereof
CN116114881B (en) * 2021-11-15 2024-08-06 华熙生物科技股份有限公司 Three-layer freeze-dried flash-release tablet containing hyaluronic acid and preparation method thereof

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Application publication date: 20120725